- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07684495
Aerobic Exercises Versus Sub Occipital Myofascial Release on Memory Function in Females With Premenstrual Syndrome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The pooled prevalence of reproductive age women affected with premenstrual syndrome (PMS) worldwide amounts to 47.8%. Among these, about 20% of women experience symptoms severe enough to disrupt their daily activities, and the remaining have mild to moderate symptoms. They can experience an exacerbation of insomnia, memory problems, difficulty maintaining focus, and fatigue in the both follicular phase and luteal phase, but more noticed during the luteal phase. Memory deficit could affect those women social activities and one's daily positive functioning. Therefore, some females and their providers seek alternative treatments such as Aerobic exercise which represents a cost-effective, widely available, natural, and self-administered treatment with no adverse side effects, and it is reported that Aerobic exercise resulted in 16.5% increase in hippocampal volume and 53.7% increase in memory, as well as increased hippocampal resting-state functional connectivity.
And also, it is found the noticed role of suboccipital muscles release in improving memory functions through enhancing cerebral blood flow to the brain via vertebral artery, and also regulation of cortisol level that interferes with memory and stress.
Till now, there is no previous study illustrating the difference between the effect of aerobic exercise and sub occipital muscle release on memory functions in females with PMS. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gehad Ali, Bachelor
- Phone Number: 01140675084
- Email: jihad7mohammad7@gmail.com
Study Contact Backup
- Name: Asmaa Mohammed, PHD
- Phone Number: 01005199498
- Email: Asmaa.smsm1997@icloud.com
Study Locations
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Hurghada, Egypt
- Gehad Mohamed Ali
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Females with premenstrual syndrome and memory function deficits have to meet the following criteria in order to participate in this study:
- Their age ranged from 18 to 30 years old.
- Their body mass index (BMI) ranged from 18.5 - 30 kg/cm2.
Exclusion Criteria:
- Any medications that can affect central nervous system or memory function.
- Any neurological disorders affect their memory function.
- Pregnant women.
- Daily smokers.
- Had a concussion or head trauma within the past 30 days.
- Took any illegal drugs or alcohol within the past 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Aerobic exercise group
The participants will receive aerobic exercise program for 30 minutes, 3 sessions per week for 6 weeks.
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A moderate-intensity aerobic exercise session on a treadmill consists of three phases: warm-up, active phase, and cool-down.
The warm-up lasts 5-10 minutes and involves walking at minimum speed (2.0 - 3.0 km/h) with a slight incline (1 -2%) or as tolerated.
The active phase, lasting 20-30 minutes, maintains a brisk walking or light jogging pace with moderate speed (4.5-6.5 km/h) or as tolerated.
This phase can include steady-state jogging or intervals of walking and jogging to sustain cardiovascular engagement.
Finally, the cool-down phase lasts 5-10 minutes, where the speed is gradually reduced to 2.0 - 3.0 km/h, allowing the heart rate to decrease safely.
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Experimental: Sub occipital myofascial release group
The participants will receive sub occipital myofascial release treatment 3 sessions per week for 6weeks.
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The patient will be asked to take a supine position, and a pillow will be placed under the patient's head for comfort until starting the procedure, the patient will be instructed to be relaxed, then the therapist will sit at the head of the bed and will place both hands underneath the patient's head in the occipital region.
The therapist should then feel for the occipital ridge along the scalp and move the hands slightly caudal until the muscle is felt.
The therapist then will flex the fingers upward against the suboccipital muscles and this position will be hold for 3 to 5 minutes or until significant muscle tension will be released.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Memory function
Time Frame: 6 weeks
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Assessment of memory function will be done by the free recall test. The word list will contain 10 words selected randomly. These words would be administered to the patient one by one with interval time 1 second between each word with total words presentation time 10 seconds. The presentation of these words will be though a digital screen using a designed video showing these words arranged in order with a fixed interval 1 second between each word. The patient will be instructed immediately to recall these words verbally at any order. The total score is 10 and one point will be accounted for each word will be recalled correctly |
6 weeks
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Prospective and retrospective memory questionnaire (PRMQ)
Time Frame: 6 weeks
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It will be used to assess memory functions. The measure consists of 16 individual items. The Structure of the PRMQ consists of 16 Items total , each item is rated on a 5-point scale (1 = Never , 2 = Rarely , 3 = Sometimes , 4 = Often , 5 = Very Often). These 16 items, evenly divided into 8 prospective memory items and 8 retrospective memory items. Each item describes a common memory lapse, giving a high score to an item means a high memory deficits at that item. The total score ranges from 16 to 80, with higher scores indicating a greater frequency of memory lapse and deficit. |
6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perceived Stress Scale (PSS)
Time Frame: 6 weeks
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The Perceived Stress Scale (PSS) is a widely used self-report instrument developed to to assess the degree to which individuals perceive situations in their lives as stressful during the previous month.
The most commonly used version, the 10-item Perceived Stress Scale (PSS-10), consists of 10 questions rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often).
Participants complete the questionnaire independently, the total score is obtained by summing the responses to all items, resulting in a score ranging from 0 to 40, with higher scores indicating greater perceived stress.
Although there are no universally accepted cut-off values, scores of 0-13 are generally considered to indicate low perceived stress, 14-26 moderate perceived stress, and 27-40 high perceived stress.
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6 weeks
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Cervical pain intensity
Time Frame: 6 weeks
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The Visual Analogue Scale (VAS) will be used to assess pain intensity.
It is a simple, valid, and reliable self-report instrument widely used to assess the intensity of subjective symptoms such as pain, stress, fatigue, and mood.
It consists of a 10-cm horizontal line with two endpoints representing the extremes of the symptom being measured (e.g., "no pain" at one end and "worst imaginable pain" at the other).
Participants are instructed to place a mark on the line at the point that best represents the intensity of their current symptom.
The score is determined by measuring the distance in millimeters or centimeters from the left endpoint to the participant's mark, yielding a value ranging from 0 to 100 mm (or 0-10 cm), with higher scores indicating greater symptom intensity.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amel Youssef, Professor, Cairo university
- Study Director: Elham Hassan, As Professor, Cairo university
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006325
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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